FDA.reportPublic FDA data

MAUDE MDR 9159264

MDR report key
9159264
Report number
1218996-2019-00017
Event key
0
Event type
3
Date of event
2014-10-22
Date received
2019-10-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. IVY MARGARET THIONG'O
Address
101 BILLERICA AVE BUILDING 4 N. BILLERICA MA 01862 US
Phone
978-978-9783
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEADCARE ULTRA CONSUMABLESLEADCARE ULTRAMAGELLAN DIAGNOSTICS, INC.DOFLEADCARE ULTRA70-80981312BUY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-040

Event Narratives#

No narrative records found.